Device and method for reducing urinary retention

ABSTRACT

A device to facilitate urination by a male includes a vessel having a contact surface area at and adjacent a top edge of the vessel configured to be placed in contact with the penis. The contact surface area includes a thermally conductive material and has a shape configured to reduce pressure requirements for urination from a standing position as compared with urinating into a toilet from a standing position. A method of reducing urinary retention in a male includes contacting the penis of the male with a contact surface area of a device, which may be as described above, and urinating while the male is in a standing position with the penis in contact with the contact surface area, wherein the contact surface area comprises a thermally conductive material and is at an initial temperature at least 14° F. lower than a temperature of the penis.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of Ser. No. 17/557,099,filed on Dec. 21, 2021, which is a continuation-in-part of applicationSer. No. 17/342,272, filed on Jun. 8, 2021, now U.S. Pat. No.11,213,421, the contents of which are hereby incorporated herein byreference in their entireties.

BACKGROUND OF THE INVENTION

Benign prostatic hyperplasia (BPH) typically begins after the age offorty, and half of males fifty and over are affected. By the age ofeighty, 90% of males are affected.

Various pharmacological treatments exist, including, inter alia, alphablockers such as tamsulosin, 5α-reductase inhibitors such asfinasteride, and phosphodiesterase type 5 inhibitors, such as tadalafil.Unfortunately, pharmacological treatments are not always completelysufficient to the task.

Various surgical and non-surgical interventions are also employed, suchas prostate surgery, including inter alia the use of devices likeUrolift®. Urolift® is an FDA-approved implanted device placed throughthe obstructed urethra, and placed permanently to hold the enlargedprostate tissue out of the way and increase the opening of the urethra.

Other interventional procedures include transurethral microwave therapy(TUMT). TUMT employs a microwave antenna attached to a flexible tubethat is inserted into the bladder, and microwave heat is used to killoff excess prostate tissue.

Laser surgery is also used to destroy prostate tissue and shrink thegland.

Transurethral incision of the prostate (TUIP) is another surgicalsolution. It involves cuts being made in the prostate to reduce theprostate's pressure on the urethra, and may be recommended for smallerprostates. One downside is the frequent need to repeat the procedure.

The most common surgery for BPH is transurethral resection of theprostate (TURP). In TURP, the physician removes portions of the prostateusing a scope inserted through the urethra.

These various surgical interventions involve known side effects, some ofwhich are serious and have adverse quality of life implications.

BPH is characterized by a spectrum of obstructive and irritativesymptoms, known collectively as LUTS (lower urinary tract symptoms).Poor urinary flow and the sensation of incomplete bladder emptying arethe two symptoms that correlate most closely with the eventual need forprostate surgery. Untreated, a significant number of men with BPH willeventually develop acute urinary retention.

Urinary catheters are frequently used to empty the bladder where thebladder is not voided adequately by the patient, and in some casespatients will be asked to self-administer catheters. This is obviouslypainful, uncomfortable, inconvenient, and demoralizing.

The demoralizing aspects of poor urine streams and sleep interruptionshould not be discounted as a critical quality of life issue forafflicted men.

It is noted that BPH is not the sole cause of urinary retention in men.Decreased contractility of the detrusor muscle can also make itdifficult to effectively empty the bladder, and impossible to fullyempty the bladder.

Known causes of urinary retention include bladder issues such as:detrusor sphincter dyssynergia, neurogenic bladder, iatrogenic scarringof the bladder, and other bladder issues

Prostate related causes of urinary retention include BPH, prostatecancer, pelvic malignancies, and prostatitis.

Urinary retention is a common pre and post-operative condition thatdisproportionally impacts older men. Medications are available to aid invoiding but they usually do not result in the voiding of residualbladder urine.

Regardless of any invasive or non invasive surgical procedures, it iscommon for incomplete bladder emptying to continue with its accompanyingurinary urgency and need for double voiding. Hence the invention.

A post-void residual urine of any amount is significant and increasesthe potential for recurring urinary tract infections stone formation andperhaps most importantly contributes to a lesser quality of life in theday and increased trip to the bathroom at night while trying to sleep.They can also interrupt day time activities.

Most people wake up once or twice during the night. Reasons this mighthappen include drinking caffeine or alcohol late in the day, a poorsleep environment, a sleep disorder, or another health condition, suchas BPH. When a person cannot get back to sleep quickly, that person doesnot get enough quality sleep to keep refreshed and healthy.

Urinary retention, apart from discomfort and practical quality of lifeimplications, also results in residual urine or urinary stasis, whichcan lead to an increased risk of urinary tract infection, bladder stonesand other consequences such as atrophy of the detrusor muscle, atonicbladder, hypertrophy of the detrusor muscle, diverticula, hydronephrosis(congestion of the kidneys), and others.

BRIEF SUMMARY OF THE INVENTION

The present invention relates, inter alia, to a device to facilitateurination by a male, comprising a vessel having a contact surface areaat and adjacent a top edge of the vessel configured to be placed incontact with the penis and/or scrotum, the vessel being capable ofcollecting urine, wherein the contact surface area comprises a thermallyconductive material, and wherein the contact surface area has a shapeconfigured to reduce pressure requirements for urination from a standingposition as compared with urinating into a toilet from a standingposition.

The thermally conductive material may have a thermal conductivity ofgreater than 20 watts per meter-kelvin.

The contact surface area may be at least 0.5 square inches, preferablyat least 1 square inch.

The contact surface area of the vessel may slope inwardly from the topedge of the vessel toward the bottom of the vessel.

When the top edge of the vessel is horizontal, the contact surface areamay be at an angle of less than 45° to vertical.

The vessel or device may have a protrusion with a contact surface areato facilitate contact with the scrotum to assist with and promoteurination. In certain embodiments, the protrusion extends from the sideof an otherwise cylindrical vessel.

The contact surface area may have an angled, curved or concave shape toincrease contact with the penis. The top edge of the vessel may have anhourglass shape comprising two wider portions forming openings separatedby a narrower portion.

The contact surface area may comprise at least one material selectedfrom the group consisting of stainless steel, steel, silver, aluminum,tin, copper, nickel, zinc, iron, magnesium and brass. Thermallyconductive additives including without limitation specialty graphitefibers may be employed. Thermoconductive plastics may be used (forexample and without limitation, Therma-Tech thermally conductiveformulations from PolyOne). Thermoconductive ceramics may be employed.

The vessel may include markings to show volume.

The vessel may comprise an antimicrobial coating on its surfaces.

The contact surface area may comprise a thermally conductive materialpreferably having a thermal conductivity of at least 20 watts permeter-kelvin. At least some portions other than the contact surface areaof the device may comprise a material having a thermal conductivity lessthan that of the contact surface area. Such embodiments may be desirableto retard the transfer of heat from urine to the contact surface area.Non limitative embodiments include a vessel with a lower portion madefrom a relatively non-thermoconductive material mated to an uppercontact surface portion comprising a more theromconductive material. Inyet another embodiment, the non-contact surface area is insulated with aless-thermoconductive coating or layer to retard heat transfer fromurine during use. Generally, such coating or layer will correspond (orexceed) the urine contact surface area.

The present invention also relates to a method of reducing urinaryretention in a male, comprising contacting the penis of the male with acontact surface area of a device and urinating while the male is in astanding position with the penis in contact with the contact surfacearea, wherein the contact surface area comprises a thermally conductivematerial and is at an initial temperature at least 14° F. lower than atemperature of the penis.

Embodiments of the present invention may be used in any position—notmerely a standing user.

The device used in the method may be as described above and hereinafter.

The device may be used to treat urinary hesitancy in men who do notsuffer from BPH; for example, the device may be used for men with malevoiding dysfunction. For example, certain men suffer from poorcoordination between the bladder muscle and the urethra. This may resultin incomplete relaxation or over-activity of the pelvic floor musclesduring voiding. Voiding symptoms represent a continuum of what isreferred to as Lower Urinary Tract Symptoms (LUTS), which may be treatedwith embodiments of the current invention.

Embodiments of the present invention may also be used to treat pelvicfloor hyperactivity, neuro-sensory dysregulation within the bladderwhich can be reflected as sensory instability, inappropriate bladdercontractions, bladder hyperreflexia, poor bladder compliance, orneuro-sensory dysregulation. Treatment with the device may assist insuccession urination, including as self-reported by patient-users ascompared with a control group.

Embodiments of the present invention may be used to treat overactivebladder.

Embodiments of the present invention may be used to treat neurogenicdetrusor overactivity.

Use of embodiments of the present invention may be used to reduce scoreson the International Prostatism Symptom Score (IPSS) test as comparedwith non-users or users of a control. IPSS refers to the InternationalProstate Symptom Score. The IPSS may be reduced by 2 or more points,preferably by 3 or more points, most preferably by 5 or more points, ascompared with a control group.

Embodiments of the present invention may be used to reduce nocturia, ascompared with non-users or users of a control. Preferably nocturia arereduced (per sleep cycle) by 0.5 times or more, more preferably by 1time or more, still more preferably by 2 times or more.

Embodiments of the present invention may be used to increase averagetotal sleeping time, by reducing nocturia and/or otherwise extendingtime between nighttime voids. Users may increase their average totalsleep time (as compared with a control group) by at least five minutes,preferably by at least ten minutes, more preferably by least fifteenminutes, most preferably by at least twenty minutes.

Embodiments of the present invention may be used to increase averagetotal rem sleeping time, by reducing nocturia and/or otherwise extendingtime between nighttime voids. Users may increase their average total REMsleep time (as compared with a control group) by at least five minutes,preferably by at least ten minutes, more preferably by least fifteenminutes, most preferably by at least twenty minutes.

Embodiments of the present invention may be used to reduce the number ofsmall urinary evacuations (defined here as urinations under 50 mlvolume) as compared with non-users or users of a control. Preferably,small urinary events are reduced by at least 0.5 per day, preferably byat least 1 per day, more preferably by at least 1.5 per day.

Embodiments of the present invention may be used to extend the longestduration between urinations for a group of users, as compared with acontrol group of non users (measured as the longest duration betweenvoids during a day, such longest void times added and divided by thenumber of days to reach an average). Embodiments of the presentinvention may extend the average longest duration between urination byat least fifteen minutes, preferably by at least thirty minutes, morepreferably by at least forty-five minutes.

The method may further comprise treating the male with a drug therapy,including without limitation a drug therapy selected from the group ofalpha blockers, 5α-reductase inhibitors and phosphodiesterase type 5inhibitors. The method may further comprise treating the male with drugtherapy for overactive bladder syndrome.

The method may further comprise at least one additional urination priorto urinating while the male is in a standing position with the penis incontact with the contact surface area, wherein a void interval betweenurinations is less than twenty minutes, less than fifteen minutes, lessthan ten minutes or less than five minutes.

Embodiments of the present invention may be used to reduce the time todouble void, by making it easier for the user to initiate a double void.The invention, as compared with a control group, may permit a group ofpatients to double void within shorter intervals than the control group.The average double void time may be 10% faster, preferably 20% faster,most preferably 30% faster, on average, than the control group.

Embodiments of the present invention may be used to facilitate increaseduse of double voids by making it easier to initiate such double voids.Embodiments of the present invention may be used to increase the numberof double voids (defined as a second void within twenty minutes of thepreceding void) by users. As compared with a control group, users mayincrease their double void activity by at least one double void per day,preferably by at least two double voids per day, more preferably by atleast 2.5 double voids per day.

Embodiments of the present invention may be used to reduce urinarydribbling as compared with a control group of non-users or placebo.Dribbling is a significant quality of life issue. As compared with acontrol group of non-users, use of embodiments of the present inventionmay statistically reduce the occurrence of dribbling episodes, by 1 ormore times per week, preferably by 3 or more times per week, morepreferably by 5 or more times per week.

Reduction of incontinence episodes in patients with overactive bladdersyndrome may be more dramatic. Embodiments of the device may reduce thenumber of daily incontinence episodes by 0.5 per day, preferably, 1 perday, more preferably 1.25 per day, most preferably 1.5 per day. Theseresults are comparable to the efficacy of Myrbetriq®.

The device may be co-administered, used or prescribed in conjunctionwith drugs uses to treat overactive bladder syndrome.

The method may further comprise at least one additional urination priorto urinating while the male is in a standing position with the penis incontact with the contact surface area, wherein a void interval betweenurinations is less than ten minutes, and the retained urine in thebladder is reduced at least 20% for a given patient population (ascompared to a control group urinating in a standing position into atoilet or wall urinal, or other control conditions).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of the device of thepresent invention, with penis inserted, using an hourglass (orfigure-eight shape) for the vessel for maximal skin exposure.

FIGS. 2A and 2B contrast the urine stream pressure required to reach atoilet from standing position (FIG. 2A) and the pressure required tourinate in the device of the present invention (FIG. 2B).

FIG. 3 is a device that is made from two distinct materials.

FIG. 4 is a device with a curved area to increase surface contact withthe penis.

FIG. 5 has a “ski slope” feature to increase surface contact area withthe penis.

FIG. 6 has a protrusion to promote contact with the scrotum.

DETAILED DESCRIPTION OF THE INVENTION

One embodiment of the invention is a vessel made of a high thermaltransfer material, in which is placed the penis of a standing man,preferably with the device touching directly or indirectly the scrotum,transfers heat from the body to the vessel, and assists in passing urineand reducing retention of urine in the bladder. This transfer involvesthe loss of penile (and/or scrotum) heat (perceived coldness) to thevessel. The device is not intended by itself to be a treatment for BPHbut is meant as a key adjunct to medication and surgical typeprocedures. While the physiological reason for the device assisting inpassing urine and reducing retention of urine in the bladder is notcompletely known, it is postulated that, the device assists in passingurine and reducing retention of urine in the bladder because of thermalconductivity (described hereinafter) and because the pressure of astanding male, whose penis is directed downwards in its naturalposition, avoids kinks in the urethra when voiding which might otherwisebe caused by the growing inelasticity of the male's urethra with aging.In addition, the use of the device reduces pressure required to propelurine on a forward trajectory to a toilet or urinal.

In adults older than 50 years, 30-100 ml or more of residual urine mayremain after each voiding because of the decreased contractility of thedetrusor muscle or lack of sufficient pressure to expel urine into thetoilet bowl. There may be a lack of a stimulus to release the urinarysphincter musculature. In retention, ultrasound of the bladder may showincrease in bladder residual urine.

The present invention relates to a non-invasive device that can be usedto reduce or effectively eliminate urine retention; we call this devicethe virtual catheter. The virtual catheter is a vessel used to collecturine, typically from a standing male (though the virtual catheter maybe used from non-standing positions)

The virtual catheter device, described herein, provides thermaltransfer, reduced pressure and unknown neurogenic based stimulus torelease the urinary sphincter and initiate and continue urination, andhelp the user of the virtual catheter to more fully evacuate the bladderof urine.

By placing the penis into the high thermal transfer vessel, made of,e.g., metal such as stainless steel, shaped as to maximize contact withpenile skin and ideally, also directly or indirectly holding the deviceagainst the scrotum, preferably while the man is standing, whichincreases gravitational pressure and reduces pressure needed to pushurine forward to a toilet, it becomes far easier to release thesphincter and void into the vessel and more completely empty thebladder. In terms of temperature, the vessel may be at room temperaturelet us say 70 degrees F. and the penile and scrotal skin may be at bodytemperature of approximately 98.60 F or slightly, lower. This effect inthe standing position with accompanying increased pressure, causes morecomplete voiding (though not requiring the pressure required to directurine to a conventional toilet). The inventors are not aware of thistemperature effect ever being used in a method or device for passingurine and/or reducing retention of urine in the bladder. However, anurge to urinate may be experienced by men with BPH when coming insidefrom a zone of different temperature, such as coming into a warmbuilding from the cold. The neurogenic reason for the temperature effectis not determinable.

The device may feature a contact area for the scrotum, typically aprotrusion or raised area that rises away from the shape of the vessel.The contact area is typically a discreet protrusion, rather than aprotrusion that goes all the way around the vessel, so as to avoidinterference with the handle. However, it is possible to have aprotrusion that goes all the way around the vessel that does notinterfere with the handle. The protrusion has a contact surface areathat typically will have identical or comparable thermoconductiveproperties as the contact surface area for the penis itself. Theprotrusion allows for an ergonomic fit wherein the scrotum is contacted.

While it is expressly contemplated that the vessel can be used fornon-BPH patient populations, it is generally desirable that the vesselbe of a suitable weight for an older person to comfortably hold.Preferably, the dry weight of the vessel is less than 750 grams,preferably less than 650 grams, more preferably less than 550 grams, andmost preferably less than 500 grams. These mass ranges are notlimitative.

Now this non-intrusive device allows for the more complete passage ofurine, more complete emptying of the bladder even after a user's doubleurinary void in the toilet (see testing results discussed below). Thisis especially useful at night after the double void but is also usefulin the daytime after a single void in the toilet and again as can beseen in a test subject. It increases the time interval wherein the urgeto void returns. In certain embodiments, in increases the time betweenvoids by many minutes. Average times between voids for a given group(measured as average time between voids, excluding double voids) may beincreased by seven minutes or more, preferably ten minutes or more, morepreferably 12 minutes or more, most preferably 18 minutes or more ascompared with a control group. The average void times may be measured ona 24 hour cycle, or measured during the day or non-sleeping cycles.

In addition, it has been found that it can reduce the time intervalbetween the first and second void, (IBD) by use of the vessel describedfor the second void.

It is a purpose of the virtual catheter device to facilitate urinationusing thermal conductivity—using a temperature stimulus—on the penis andoptionally the scrotum, directly or indirectly, as well as reducingrequired pressure since the patient is standing and the penis ispointing downward in its usual position therefore avoiding any kinkingof the urethra in the older individual with less tissue elasticity

A device may be made that creates the thermoconductive effect of thepresent invention but is easy to use when the user is seated on thetoilet. Such a device may comprise a contact surface for the penisand/or scrotum but not be a vessel for receiving or collecting urine,since it may be difficult to maneuver the vessel into place for a userseated on toilet. In such a configuration, the device may be amanageable stick-like device with contact surface area for the penis andor/scrotum that can be comfortable contacted with the penis in anon-standing position, for example a user on the toilet.

There is a need for a non-invasive treatment to reduce urinaryretention.

It is an object of certain embodiments of the present invention toassist a patient in more consistently evacuating the bladder, i.e.,substantially reducing or eliminating retained urine in the bladder.Retained urine volume may be, for a given urination protocol, may bereduced at least 10%, preferably at least 20%, more preferably at least30%, most preferably at least 40% for a given patient population ascompared with a control group. Retained urine may be measured aftervoiding, after double voiding, or measured using random or set testprotocols.

It is an object of certain embodiments of the present invention toextend or prolong sleeping intervals for patients that are otherwiseawoken by urinary urgency, including inter alia users who suffer withBPH.

Shortening double or triple void times can make it easier for patientsto fall back asleep by reducing the period of time between voids duringwhich time a patient may become distracted, become fully awake, and havea harder time falling back asleep. This reduces their total sleep time.Such periods of being awake may also reduce the activity of antidiuretichormone (ADH).

Improvement in sleep—whether total sleep, interrupted sleep intervals,increases in REM sleep—can all significantly improve quality of life forpatients with urinary issues.

Normally, the amount of ADH in the body is higher during the night. Thishelps prevent urination while you are sleeping. But if the levels of ADHremain low during the night, the body will produce large amounts ofurine, so urination during the night is more likely. Hence theimportance of the reduced DVI so as to not reduce ADH formation.

It is an object of certain embodiments of the present invention toreduce the risk (and frequency) of urinary tract infections (UTI). It isan object of embodiments of the present invention to reduce theprevalence of UTI in adult males (including adult males with BPH) by atleast 15%, preferably by at least 20%, most preferably by at least 25%,as compared with a similarly aged, healthy control group.

It is an object of certain embodiments of the present invention toreduce urinary tract infections, in incidence and/or severity, on astatistically significant level.

It is an object of certain embodiments of the present invention toreduce or eliminate the formation of bladder stones, through a modalityof reducing or eliminating retained urine. It is an object of certainembodiments of the present invention to reduce the incidence of bladdercalculi in men with BPH by at least 2.5%, preferably by at least 10%,most preferably by at least 20%, as compared with a similarly aged (orotherwise appropriately batched), control group not using the virtualcatheter.

It is an object of certain embodiments of the present invention toreduce or eliminate the need for conventional catheter placement aftercertain urological procedures, increasing patient comfort, decreasingthe need for follow on medical care, and reducing the risk of scarringand other tissue damage for urethral catheter insertion.

It is an object of certain embodiments of the present invention toemploy the virtual catheter as a diagnostic device to ascertain retainedurine after conventional urination (potentially replacing the need forultrasound or other imaging to determine retained urine after thepatient pees).

It is an object of certain embodiments of the present invention to allowa user of the virtual catheter to track urine collection over time.

It is an object of the invention to reduce the time interval betweendouble voiding, the double voiding interval (DVI). Double voiding isalmost universally recommended in all patients with BPH.

In certain embodiments, the virtual catheter is prescribed for a patientin conjunction with a pharmaceutical agent, including withoutlimitation, one or more of: alpha blockers such as tamsulosin,5α-reductase inhibitors such as finasteride, and phosphodiesterase type5 inhibitors, such as tadalafil. The virtual catheter may be prescribedor used with other drug therapies, and or device therapies. In certainembodiments, the virtual catheter is prescribed together with one ormore of the above-reference drugs, optionally as a drug-devicecombination.

Embodiments of the present invention promote more complete urinary flowand prevent dribbling.

Embodiments of the present invention comprise a non-invasive device thatis placed in contact with the penis prior to, and during, urination.

Typically, the user's urine is collected in the device, and then emptiedby the user.

Typically, the device is used by a standing user, but it is possible touse the device in a non-standing position. The ability to stand usingthe virtual catheter is a significant advantage; many older males findit uncomfortable to repeatedly sit and stand from the toilet,particularly in view of their frequent urination patterns.

Embodiments of the present invention comprise a cup or vessel.Optionally, the outer margin is ergonomically designed to increasesurface area contact between the upper edge of the cup shaped device andthe penis. Optionally, the upper, inner portion is ergonomicallydesigned to increase surface area contact between the upper, innerportion of the cup shaped device and the penis.

Two mechanisms are employed, which are both novel to the literature andmedical practice.

The first mechanism is the use of a temperature differential as astimulus. The second mechanism is in the reduction of required pressure.The combination of these two mechanisms provides improved results.

In embodiments of the present invention, the penis is placed against amaterial that is lower in temperature surface body temperature (here,temperature of the penis). This temperature differential is preferablyat least 15° F., preferably at least 20° F., more preferably at least25° F., and most preferably at least 35′ F.

Normal temperature of a flaccid penis is 91.7″ F to 92.8° F., asreported in the literature. Thus, a cup shaped device at ambienttemperature of 75° F. will have a temperature differential with thepenis of approximately 17° F. Now, according to Vivint.com, the averageambient temperature of a home is 68 to 76 degrees(https://www.vivint.com/resources/article/best-home-room-temperature—linkretrieved on Jun. 7, 2021). The result is that ambient temperature in ahome will tend to generate a significant temperature differential.

Preferably, the temperature differential is 15-40° F., preferably 25-35°F.

Rarely, it may be advantageous to chill the virtual catheter totemperatures below ambient temperatures. In such cases where the virtualcatheter is chilled, a larger temperature differential will be achieved,i.e., a temperature differential of greater than 40° F.

In certain embodiments, the virtual catheter is sold, supplied,marketed, and/or approved for sale in conjunction with a cooler orrefrigerator unit. Such unit may further charge the virtual catheterwhere the virtual catheter has a battery, Cooling and refrigeration maybe combined with a cleaning system as part of the same or differentunits.

In certain embodiments, some or all of the material comprising thecontact surface with the penis (and/or scrotum), are selected forthermal conductive properties. Generally, the higher the thermalconductive properties, the greater the effect of the temperaturedifferential on promoting urinary flow.

Preferably, the contact surface area is comprised in part, substantiallyor entirely, of a material with a high thermal conductivity, measured inwatts per meter-kelvin, of greater than 20, preferably greater than 100,more preferably greater than 200, and most preferably greater than 300watts per meter-kelvin.

A preferred thermal conductivity range for the contact surface area is20 to 500 watts per meter-kelvin.

Generally, the contact surface area must be adequate to provide asufficient temperature-based stimulus.

In certain embodiments, the contact surface area between the vessel andthe penis is at least 0.5 inch², preferably at least 0.75 inch², morepreferable at least 1 inch², and most preferably at least 1.25 inch²,measured as an average for a typical group of users (which may begeneral users or a specific sup-population of users).

In certain embodiments, the contact surface area between the vessel andthe scrotum is at least 0.25 inch², preferably at least 0.5 inch², morepreferable at least 0.8 inch², and most preferably at least 1 inch²,measured as an average for a typical group of users (which may begeneral users or a specific sup-population of users).

In other embodiments, the internal wall of the virtual catheter will besloped inwards to accommodate contact area between member and receptablewall, i.e. the penis is supported on the inward-sloping surface.Preferably, substantially all or all of the contact surface area is ahigh thermally conductive material.

In other embodiments, the virtual catheter will comprise a short rampportion, akin to a ski jump, to accommodate the member and provideadditional contact surface area. The ski jump is angled downwards fromthe plane of the top of the virtual catheter, in most embodiments.Generally, it is desirable that the “ski jump” be short enough for thetip of the penis to extend past it. The “ski jump” may be concave inshape to facilitate additional contact surface between penis and the“ski jump”.

Concave, curved, or angled shapes to promote contact surface area may beemployed in various designs. The vessel may use a tighter curve toincrease contact surface area; a figure eight shape may be useful tohave two ends with a tighter curve than would be the case for acomparably sized cylindrical design. and the handle convenient for aright or left handed person.

The geometry of the virtual catheter is important. As a receptable, thevirtual catheter has a receptable function and typically will take thegeneral form of a cup. It is not necessary for the virtual catheter totake the form of a cup, as the essential functionality is delineatedabove as a function of temperature stimulation and reducing pressurerequirements.

The virtual catheter may channel urine into a toilet or other propersewer, e.g., by means of a tube extending from the bottom of the vessel;it may use a separate disposable collection depot like a conventionalcatheter bag, provided that the virtual catheter has the ability toprovide temperature stimulation to the penis and or scrotum, and reducepressure requirements. It is conceivable that the device and method ofthe invention can use a tube having thermal conductive propertiesconfigured to be placed around the shaft of the penis during urination.Nonetheless, a cup like shape is the preferred embodiment.

In preferred embodiments, the weight of the virtual catheter should becomfortable to hold. Typically, the virtual catheter will have at leastone external handle. The virtual catheter may have more than oneexternal handle, for example and without limitation, two handles.

The virtual catheter is intended for use when the patient is standing,but may be used in other positions.

In certain embodiments, the vessel may be comprised of differentmaterials or difference surfaces. As a non-limitative, example, thevessel may have a contact surface area made from stainless steel and therest (or other parts) of the vessel may be made from a plastic.

The interior of the vessel have be made from, or have a coating or otherapplication of relatively insulative material to prevent urine fromwarming the contact surface area(s) during use.

Recovery of the temperature differential between the virtual catheterand body temperature must be considered. The use of a urine-contact areawith low thermal transfer properties can speed recovery. By urinecontact area, we mean the portion of the vessel in contact with urineafter urination into the vessel (i.e. where the urine tends to flow intothe vessel—the bottom portion), understanding that there may beincidental deposit of urine on the intended contact surface area for thepenis.

Preferably, the urine-contact area surface has a thermal conductivity ofless than 5 watts per meter-kelvin, preferably less than 1, morepreferably less than 0.5, and most preferably less than 0.3 watts permeter-kelvin.

The interior of the cup device may be scored or otherwise marked to showvolume of collected urine. The exterior of the cup may be scored orotherwise marked or designed to show volume of collected urine,particularly where the cup has a transparency to see the internalamount.

In certain embodiments, the device has a white interior in whole or inpart (e.g., on the bottom) to facilitate colorometric analysis of theurine.

In certain embodiments, the device may be clear or transparent in wholeor in part (e.g., on the bottom) to facilitate colorometric analysis ofthe urine. The device may comprise a light source to facilitatecolorometric analysis.

In certain embodiments, the vessel is treated in whole, in part, orsubstantially with an anti-microbial coating, it being noted that it isimportant not to adversely affect the thermal conductive properties ofthe contact area in preferred embodiments.

As an alternative to coatings, materials may be employed whichthemselves have antimicrobial, anti-bacterial, or anti-fungal activity,e.g. (and without limitation) copper or silver.

In certain embodiments, the virtual catheter device may comprise asensor to measure urine collected. The device may comprise a clock ortimer to record the time of urine collections. The device may comprise adissolved solids meter. The device may comprise a thermistor ortemperature sensor. The device may contain optical sensors, or othersensors to determine the value of an analyte. The device may contain acamera. The cup device may have wifi, Bluetooth, cellular, or otherconnectivity. The device may be capable of using connectivity to conveythe time, duration, amount, flow rate, flow rate duration (andcommencement and conclusion), temperature, dissolved solids, analytelevels, analyte measurements or other collected information to adatabase. Such a database may be in the cloud, on a computer, a phone orapp. The database may be accessible by a patient, caregiver, physician,or other medical professional, and may be subject to pre-set alerts.Particularly as it relates to alerts, the contents of the presentapplicant's U.S. Pat. No. 7,824,612 are hereby incorporated by referenceherein as if fully set forth herein. Such features may be particularlyuseful to monitor patients post urology procedures including surgicalprocedures.

In certain embodiments, the device may receive or otherwise be intendedand/or designed to work with reagent sticks or strips (or other reagentembodiments) for diagnostic purposes.

In certain embodiments, the device may have a high thermal conductivityneck (and/or scrotum contact surface area) with an accordion like bottomso that it is more portable for travel.

In certain embodiments, the device has a vibratory feature foradditional stimulus. The vibratory feature may be turned on using abutton, or automatically be triggered by a light sensor, motion sensor,liquid sensor, or other sensor. Optionally, the device comprises a powersource, such as a battery.

The virtual catheter may be supplied as part of a kit with specificcleaning materials and procedures. The virtual catheter mayalternatively be supplied with a cleansing device that is capable ofadequately cleaning and/or sterilizing the device. Cleansing methods mayinclude the use of temperature, cleaning agents, and ultraviolet orother light wavelengths.

It is advantageous that the urinary virtual catheter be readilyidentifiable for its intended use, and not readily confusable with otheritems. Markings, indicia, and colors may be used for this purpose.

It is important to note that urine is normally free of bacterialcontamination. In certain instances, in emergency situations, it hasbeen recommended to clean a wound with one's own urine.

In certain embodiments, the virtual catheter is a disposable, single usedevice. Typically, the single use version will have a metal rim, with apaper or plastic lower collection portion. However, the disposable unitmay be all metal or all thermoconductive material. Optionally, thesingle use device folds like an accordion, or otherwise can be folded orcompacted for ease of portability before use.

FIG. 1 is a perspective view of one embodiment of the device of thepresent invention, with penis inserted, using a figure-eight shape forthe vessel. The device 1 of this embodiment includes a vessel 2 having ahandle 4. An upper lip or edge 6 of the vessel 2 forms an opening 8. Theupper lip or edge 6 of the vessel 2 forming the opening 8 (andcross-sectional shapes of the vessel 2 for at least a portion of thevessel adjacent the top edge 6, in planes substantially parallel to anupper lip/opening 6) may have, as shown in FIG. 1 , an hourglass (orfigure eight-like shape), i.e., two wider portions separated by anarrower portion. It is preferable but not required for the device 1 toinclude a handle 4. This shape allows for holding and use of the deviceby a right or left handed person.

The hourglass (or figure eight-like shape), or other concave, curved, orangled shapes promote greater contact surface area with the penis. Thevessel 2 or at least the portion extending downward from the upper lipor edge 6 may use a tighter curve than that shown in FIG. 1 to increasecontact surface area; a figure eight shape may be useful to have twoends with a tighter curve than would be the case for a comparably sizedcylindrical design.

The internal wall 9 of the virtual catheter may be sloped inwardly froma top edge of the vessel to accommodate contact area between the penisand the receptable wall, i.e., it is configured for the penis to besupported on the inward-sloping surface. Preferably, substantially allor all of the contact surface area (area configured to be in contactwith the penis and optionally the scrotum) or optionally all of thedevice 1 is made of or coated with a high thermally conductive material.Metals such as stainless steel, steel, silver, aluminum, tin, copper,nickel, tin, zinc, iron, magnesium (or its alloys or compounds), andbrass are non-limitative examples of materials that may be employed forat least the contact surface area.

FIGS. 2A and 2B contrast the urine stream pressure illustrated withbroken lines (and angle of the penis with respect to the vertical)required to reach a toilet from standing position (FIG. 2A) and theurine stream pressure illustrated with broken lines (and angle of thepenis with respect to the vertical) required to urinate in the device ofthe present invention (FIG. 2B). As can be seen, the device can reducethe pressure necessary to expel urine as compared to reaching a toiletfrom standing position.

In certain embodiments, the vessel 2 may be comprised of differentmaterials or different surfaces. As a non-limitative example, as shownin FIG. 3 , the vessel 2 may have a contact surface area 2 inches sqmade from a material with high thermal conductivity such as stainlesssteel and the non-contact portions 2″ of the vessel may be made fromless thermally conductive material such as plastic. Preferably, thecontact surface area 2′ has a high thermal conductivity, measured inwatts per meter-kelvin, of greater than 20, preferably greater than 100,more preferably greater than 200, and most preferably greater than 300watts per meter-kelvin.

The non-contact portion 2″ of the vessel has a low thermal conductivity,measured in watts per meter-kelvin, of less than 20, preferably lessthan 10, more preferably less than 2, and most preferably less than 1watt per meter-kelvin. Many plastics have a thermo-conductivity of lessthan 1 watt per meter-kelvin.

All thermal conductivity coefficients described herein area measured at20 C and 1 bar.

FIG. 4 shows a device with a curved area 10 having a radius of curvaturesimilar to a radius of curvature of a flaccid penis configured toincrease surface contact with the penis.

FIG. 5 shows an embodiment having a sloped portion 11 or “ski slope”feature configured to increase surface contact area with the penis.

FIG. 6 shows an embodiment having a protrusion 12 extending outwardlyfrom an outer wall of the vessel configured to promote and increasecontact area with the scrotum.

In certain embodiments, the internal wall 9 of the vessel 2 (or thecurved area 10 or sloped portion 11) on which the penis rests is slopedinwardly from a top edge of the vessel 2 toward the bottom such that,when the upper edge 6 and bottom surface of the vessel 2 is horizontal,the internal wall 9 of the vessel 2 (or the curved area 10 or slopedportion 11) is not vertical but is at a downward angle of less than 45°,more preferably less than 35°, even more preferably less that 30° tovertical. By inward angle slope, we mean the slope measured from the topof the vertical axis at the side of the vessel, inwards. The embodimentof FIG. 2B has a very modest inward slope, substantially less than 30degrees.

As noted infra, an inward slope may be a straight angle, but it may alsobe a generally sloped surface that is curved or otherwise angled or notshaped as a pure slope (see, e.g., FIG. 4 ).

In certain embodiments, the vessel can have an opening or openable drainnear or in a bottom surface of the vessel to drain the urine from thevessel. The drain may further connect to a tube, or a secondarycollection chamber, or other suitable receiving area for the urine.

It is contemplated that embodiments of the present invention may be usedwith various double and triple void techniques.

A non-limitative series of triple urinary iterations are contemplatedincluding inter alia: (i) toilet, toilet, vessel; (ii) toilet, vessel,vessel; (iii) vessel, vessel, vessel. A non-preferred sequence is (iv)vessel, vessel, toilet, or (v) vessel, toilet, toilet. These tripleurinary sequences are preferably completed within a total of fifteenminutes, preferably within ten minutes, more preferably within sevenminutes.

A non-limitative series of double urinary iterations are contemplatedincluding inter alia: (i) toilet, vessel; and (ii) vessel, vessel. Anon-preferred sequence is vessel, toilet. These double urinary sequencesare preferable completed within a total of twelve minutes, preferablywithin ten minutes, more preferably within five minutes, and mostpreferably within three minutes.

The void interval is the time between voids. In the case of a doublevoid, preferably, the void interval is less than ten minutes, preferablyless than five minutes, and most preferably less than three minutes. Theuse of the vessel of the current invention allows for such briefeffective void intervals, with substantial urine expulsion andminimizing retained urine.

The short duration of the complete sequences is particularly desirableto facilitate sleep, or to permit uninterrupted time during the day.

Embodiments of the present invention may be adapted for use by females.

Example A

This experiment will have 3 cups: one plastic (low thermalconductivity); one stainless steel (moderate thermal conductivity); andone copper (high thermal conductivity).

A ETEKCITY model 774 infrared thermometer was used in this experiment.

The cups were stored at room temperature ambient conditions and atemperature reading of each cup was taken with the following results:Plastic-72F; Stainless Steel-72F; and Copper-72F Next, a finger of anadult male was measured (as proxy for the penis) and showed atemperature of 92F

Then, the finger was placed in the inside of each cup, and the adultmale's temperature impression was recorded: (i) finger placed on insideof Plastic Cup . . . no distinct temperature feeling; (ii) finger placedon inside of Stainless Steel Cup distinct feeling of coolness; (3)finger placed on inside of Copper Cup . . . distinct and heightenedfeeling of cool/cold.

The conclusion of this experiment is that thermal conductivity isrelated to temperature perception/nervous system response.

Example B

In this example, an approximately 80-year old male, with BPH,volunteered to use a stainless steel vessel and a copper vessel suppliedto him, and record his results. By “use” the volunteer was instructed tourinate into the vessel while his penis was touching the inner lid.

As shown below, he typically voided his bladder as per his personalroutine in the toilet, and then afterwards used the provided vessel. Hereported his results as follow, with SS denoting stainless steel, and cudenoting copper. All voids were made standing. After urination in thevessel, the volunteer emptied the vessel into a scored beaker to measurethe volume of evacuated urine. The volume figure is the urine collectedin the vessel.

First Session, Example B

1^(st) go - - - toilet 11:30 p.m. 2^(nd) go - - - SS Cup 11:40 p.m. 70ml 1^(st) go - - - toilet 1:50 a.m 2^(nd) go - - - SS Cup 2:01 a.m.  85ml. 3^(rd) go - - - SS Cup 2:07 a.m. 50 ml 1^(st) go - - - toilet 5:03a.m. 2^(nd) go - - - SS Cup 5:13 a.m. 125 ml  1^(st) go - - - toilet7:06 a.m. 2^(nd) go - - - SS Cup 7:18 a.m. 85 ml Day 1^(st) go - - -toilet 2:45 p.m. 2^(nd) go - - - SS Cup 2:53 p.m. 50 ml

Second Session, Example B

1^(st) go 12:25 toilet 2^(nd) go 12:34 SS Cup 80 ml 3^(rd) go 12:42 SSCup 50 ml 1^(st) go 2:20 toilet 2^(nd) go 2:30 SS Cup 115 ml  3^(rd) go2:44 SS Cup 40 ml 1^(st) go 4:25 toilet 2^(nd) go 4:36 SS Cup 80 ml3^(rd) go 4:47 SS Cup 40 ml 1^(st) go 7:24 toilet 2^(nd) go 7:34 SS Cup80 ml 3^(rd) go 7:45 SS Cup 35 ml DAY 1^(st) go 1:00 p.m. toilet 2^(nd)go 1:10 p.m. SS Cup 50 ml 3^(rd) go 1:21 p.m. SS Cup 50 ml

Third Session, Example B

1^(st) go - - - toilet 11:30 p.m. 2^(nd) go - - - toilet 11:35 p.m.3^(rd) go - - - SS Cup 11:41 p.m. 50 ml 1^(st) go - - - toilet 1:35 a.m.2^(nd) go - - - toilet 1:47 a.m. 3^(rd) go - - - SS Cup 1:55 a.m. 40 ml1^(st) go - - - toilet 3:28 a.m. 2^(nd) go - - - toilet 3:35 a.m. 3^(rd)go - - - SS Cup 3:45 a.m. 50 ml 1^(st) go - - - toilet 5:40 a.m. 2^(nd)go - - - toilet 5:47 a.m. 3^(rd) go - - - SS Cup 5:55 a.m. 60 ml Day1^(st) go - - - toilet 2:30 p.m. 2^(nd) go - - - toilet 2:40 p.m. 3^(rd)go - - - SS Cup 2:47 p.m. 80 ml

Fourth Session, Example B

1^(st) go 11:40 p.m. toilet 2^(nd) go 11:50 p.m. toilet 3^(rd) go 12:05a.m. SS Cup 30 ml 1^(st) go 2:15 a.m. toilet 2^(nd) go 2:22 a.m. toilet3^(rd) go 2:30 a.m. SS Cup 40 ml 1^(st) go 4:30 a.m. toilet 2^(nd) go4:37 a.m. toilet 3^(rd) go 4:44 a.m. SS Cup 60 ml 1^(st) go 6:20 a.m.toilet 2^(nd) go 6:25 a.m. toilet 3^(rd) go 6:30 a.m. SS Cup 40 ml Day1^(st) go 2:10 p.m. toilet 2^(nd) go 2:15 pm SS Cup 110 ml 

Fifth Session, Example B

1^(st) go 12:37 a.m. toilet 2^(nd) go 12:44 a.m. toilet 3^(rd) go 12:54a.m. SS Cup 50 ml 1^(st) go 3:40 a.m. toilet 2^(nd) go 3:47 a.m. toilet3^(rd) go 3:55 a.m. SS Cup 60 ml 1^(st) go 6:15 a.m. toilet 2^(nd) go6:22 a.m. toilet 3^(rd) go 6:33 a.m. SS Cup 40 ml Day 1^(st) go 2:30p.m. toilet 2^(nd) go 2:37 p.m. SS Cup 75 ml

Sixth Session, Example B

1^(st) go 12:15 a.m. toilet 2^(nd) go 12:25 a.m. toilet 3^(rd) go 12:34a.m. SS Cup 60 ml 1^(st) go 2:55 a.m. toilet 2^(nd) go 3:05 a.m. toilet3^(rd) go 3:14 a.m. SS Cup 50 ml 1^(st) go 5:25 a.m. toilet 2^(nd) go5:34 a.m. toilet 3^(rd) go 5:42 a.m. SS Cup 40 ml Day 1^(st) go 3:05p.m. toilet 2^(nd) go 3:16 p.m. SS Cup 60 ml

Seventh Session, Example B

1^(st) go 12:10 a.m. toilet 2^(nd) go 12:19 a.m. toilet 3^(rd) go 12:28a.m. SS cup 50 ml 1^(st) go 3:58 a.m. toilet 2^(nd) go 4:10 a.m. toilet3^(rd) go 4:18 a.m. SS Cup 55 ml 1^(st) go 6:20 a.m. toilet 2^(nd) go6:26 a.m. toilet 3^(rd) go 6:36 a.m. SS Cup 50 ml Day 1^(st) go 3:10p.m. toilet 2^(nd) go 3:20 p.m. SS Cup 110 ml 

Eighth Session, Example B

1^(st) go 12:38 a.m. toilet 2^(nd) go 12:45 a.m. toilet 3^(rd) go 12:54a.m. Cu Cup 35 ml 1^(st) go 2:35 a.m. toilet 2^(nd) go 2:45 a.m. toilet3^(rd) go 2:54 a.m. Cu Cup 50 ml 1^(st) go 5:32 a.m. toilet 2^(nd) go5:42 a.m. toilet 3^(rd) go 5:50 a.m. Cu Cup 45 ml Day 1^(st) go 2:25p.m. toilet 2^(nd) go 2:30 p.m. Cu Cup 60 ml

Ninth Session, Example B

1^(st) go 12:10 a.m. toilet 2^(nd) go 12:20 a.m. toilet 3 ^(rd) go 12:35a.m. Cu Cup 40 ml 1^(st) go 3:25 a.m. toilet 2^(nd) go 3:30 a.m. toilet3^(rd) go 3:37 a.m. Cu Cup 55 ml 1^(st) go 5:55 a.m. toilet 2^(nd) go6:07 a.m. toilet 3^(rd) go 6:14 a.m. Cu Cup 35 ml Day 1^(st) go 3:50p.m. toilet 2^(nd) go 4:05 p.m. Cu cup 50 ml

Tenth Session, Example B

1^(st) go 11:30 p.m. toilet 2^(nd) go 12:10 a.m. toilet 3^(rd) go 12:20a.m. Cu Cup 40 ml 1^(st) go 3:15 a.m. toilet 2^(nd) go 3:22 a.m. toilet3^(rd) go 3:29 a.m. Cu Cup 40 ml 1^(st) go 5:10 a.m. toilet 2^(nd) go5:19 a.m. toilet 3^(rd) go 5:30 a.m. Cu Cup 50 ml Day 1^(st) go 4:00p.m. toilet 2^(nd) go 4:10 p.m. Cu cup 60 ml

Eleventh Session, Example B

1^(st) go toilet 1:25 a.m. 2^(nd) go toilet 1:32 a.m. 3^(rd) go Cu Cup1:45 a.m. 75 ml 1^(st) go toilet 6:15 a.m. 2^(nd) go toilet 6:28 a.m.3^(rd) go Cu Cup 6:44 a.m. 60 ml Day 1^(st) go toilet 4:04 p.m. 2^(nd)go Cu cup 4:12 p.m. 60 ml

Some observations are in order concerning the results of Example B.First, the test volunteer reported reduced fluid intake at the time ofthe switch from the stainless steel vessel to the copper vessel.Accordingly, this experiment was not taken to have bearing on theefficacy of these two materials.

The fact that the test subject was able to reliably expel a substantialamount of urine routinely, even after two conventional voidings in ashort period point to retained urine after normal voiding. This retainurine was substantially eliminated through use of the virtual catheter,when we compare the volume of that void to the retain urine volumesdescribed in the literature.

The test subject reported longer intervals between urination while usingthe virtual catheter, and longer sleep intervals: “ . . . gooduninterrupted sleep.”

Example C

In this example, an approximately 80-year old male, with BPH,volunteered to use a a copper vessel supplied to him, and record hisresults. By “use” the volunteer was instructed to urinate into thevessel while his penis was touching the inner lid.

As shown below, he typically voided his bladder one time routine in thetoilet, and then promptly afterwards used the provided vessel (withinthree minutes). Both voids were made standing. After urination in thevessel, the volunteer emptied the vessel into a scored beaker to measurethe volume of evacuated urine. Reports are reported below. The volumefigure is the urine collected in the vessel.

1. Toilet 10:05 2. Cup 10:06:30 65 ml 1 1/2 minute interval 1. toilet1:10 a.m. 2. cup 1:12 a.m. 70 ml 2 minute interval 1. toilet 3:45 a.m.2. cup 3:48 a.m. 40 ml 2 1/2 minute interval 1. toilet 6:30 a.m. 2. cup6:32 a.m. 60 ml 2 minute interval 1. toilet 10:05 pm 2. Cup 10:06 pm 65ml 1 1/2 minute interval 1. toilet 1:10 a.m. 2. cup 1:12 a.m. 70 mi 2minute interval 1. toilet 3:45 a.m. 2. cup 3:48 a.m. 40 ml 2 1/2 minuteinterval 1. toilet 6:30 a.m. 2. cup 6:32 a.m. 60 ml 2 minute interval

The user from these tests reported that the device allowed him toshorten his typical interval between successful double voids (DBI). Bysuccessful, we mean a void resulting in a substantial amount of urine,i.e. more than 30 ml. When urinating in a toilet, the user reported thatadditional time was often required for a successful second or doublevoid.

Example D

In this example, an approximately 80-year old male, with BPH,volunteered to use a a copper vessel supplied to him, and record hisresults. By “use” the volunteer was instructed to urinate into thevessel while his penis was touching the inner lid.

As shown below, he typically voided his bladder one time routine in thetoilet (T), and then promptly afterwards used the provided copper vessel(Cu) (within three minutes) a first time, and then a second time withinan additional three minutes. All voids were made standing. Afterurination in the vessel, the volunteer emptied the vessel into a scoredbeaker to measure the volume of evacuated urine. Reports are reportedbelow. The volume figure is the urine collected in the vessel for eachurination.

11:25 pm T 11:27 pm Cu 110 ml  3 minutes 11:30 pm Cu 30 ml 2 minutes3:15 am T 3:18 am Cu 70 ml 3 minutes 3:21 am Cu 30 ml 3 minutes 5:50 amT 5:34 am Cu 30 ml 2 minutes 5:37 am Cu 20 ml 3 minutes

The test subject noted with great pleasure that he was able to getnearly four hours of sleep (over three and a half hours) between thelast evening void and his first void during the night/early morning. Themost important issue here is the reduced DVI or ‘double voidinginterval’. Normally this individual would wait 10 or more minutesbetween the double void. Sleep studies show the longer sleep isinterrupted the more difficult it is to again fail asleep. Thisadvantage was stated by the test subject.

Example E

This example involved an experiment to null out the effect of thermaltransfer versus the effect of reduced pressure requirements to urinate.The test subject was an approximately 80 year old male with BPH. Thesubject performed all urination from a standing position, and recordedall urine volumes by transferring the urine into a scored beaker. Thesubject was told to urinate ad libitum.

For the first set of test days, the volunteer uses a paper cup, and wasinstructed to perform all urination standing, and then measure andrecord volumes. For the second set of test days, the volunteer uses asteel cup, and was instructed to perform all urination standing, andthen measure and record volumes.

For this set of experiments, the paper cup—possessing very low thermalconductivity was intended to capture/demonstrate solely those benefitsrelating to reduced pressure needed to urinate (as compared to thepressure needed to urinate into the toilet).

For the second set of experiments, the steel cup was intended to showthe incremental benefits of (cold) thermal transfer to assist ininitiation of urination as compared to the effectively non-thermalconductive paper cup, which offers reduced pressure requirements but notmeaningful (cold) thermal transfer.

For both sets of experiments, the subject noted where he urinated duringhis sleep cycle. The sleep cycle urinations are noted by the italicizedtimes.

Results are presented in the tables below.

Paper Cup Time (commenced in early Time from prior evening) Urine Volumeurination/interval 6:30 PM 50 ML 6:40 PM 60 ML 10 min 8:30 PM 110 ML 110min 8:36 PM 50 ML 6 min 8:43 PM 30 ML 7 min 10:30 PM 25 ML 103 min DayOne 12:10 AM 60 ML 100 min 1:50 AM 125 ML 100 min 1:55 AM 25 ML 5 min4:25 AM 145 ML 150 min 4:35 AM 40 ML 5 min 7:30 AM 100 ML 175 min 7:40AM 50 ML 10 min 10:30 AM 175 ML 170 min 11:45 AM 125 ML 75 min 11:55 AM50 ML 10 min 2:00 PM 100 ML 125 min 4:05 PM 50 ML 125 min 7:00 PM 125 ML175 min 9:30 PM 75 ML 150 min 9:40 PM 50 ML 10 min 11:45 PM 75 ML 125min Day Two 2:10 am 125 ml 140 min 2:20 am 35 ml 10 min 3:45 am 50 ml 85min 6:10 am 50 ml 140 min 6:25 am 20 ml 15 min 8:45 am 50 ml 140 min9:00 am 20 ml 15 min 12:20 pm 80 ml 200 min 2:35 pm 75 ml 175 min 5:00pm 100 ml 145 min 6:30 pm 75 ml 90 min 9:00 pm 75 ml 150 min Day Three1:00 AM 90 ML 240 min 1:15 AM 50 ML 15 min 3:35 AM 100 ML 140 min 3:45AM 50 ML 10 min 8:00 AM 125 ML 270 min 10:10 AM 175 ML 130 min 12:50 AM75 ML 160 min 5:30 PM 75 ML 280 min 9:10 PM 100 ML 220 min 9:17 PM 60 ML17 min Day Four 3:20 AM 200 ML 243 min 7:20 AM 100 ML 180 min 7:30 AM 40ML 10 min 11:10 AM 100 ML 220 min 11:18 AM 50 ML 8 min 1:00 PM 75 ML 102min 2:00 PM 85 ML 60 min 3:00 PM 50 ML 60 min 6:00 PM 75 ML 180 min 7:00PM 25 ML 60 min 10:15 PM 100 ML 195 min 11:30 PM 80 ML 75 min 11:37 PM80 ML 7 min Day Five 1:00 AM 60 ML 100 min 5:55 AM 150 ML 295 min 8:30AM 100 ML 155 min 8:35 AM 75 ML 5 min 10:05 AM 40 ML 90 min 11:30 am: 25ML 90 min 2:15 pm 85 ML 165 min 2:20 pm 10 ML 5 min 9:20 pm 100 ML 300min 9:30 pm 80 ML 10 min 10:30 pm 50 ML 60 min Day Six 2:00 am 100 ML210 min 5:05 am 150 ML 185 min 5:20 am 70 ML 15 min 7:15 am 50 ML 115min 8:30 am 25 ML 75 min 11:35 am 75 ML 185 min 1:00 pm 60 ML 95 min5:30 pm 125 ML 270 min 8:45 pm 125 ML 195 min 9:30 pm 125 ML 45 min 9:45pm 75 ML 15 min Day Seven 12:25 am 80 ML 150 1:50 am 0 ML (failure)  852:00 am 75 ML 10 min 6:00 am 175 ML 240 min 9:55 am 200 ML 235 min 1:00pm 100 ML 175 min 1:15 pm 75 ML 15 min 2:15 pm 100 ML 60 min 3:20 pm 50ML 65 min 4:45 pm 50 ML 85 min 8:20 pm 150 ML — 10:40 pm 100 ML 140 min10:50 pm 100 ML 10 min Day Eight 1:00 am 125 ML 130 min 1:10 am 75 ML 10min 3:30 am 100 ML 140 min 5:30 am 75 ML 120 min 5:45 am 75 ML 15 min9:30 am 100 ML 225 min 9:40 am 50 ML 10 min 10:25 am 50 ML 45 min 12:30am 50 ML 125 min 2:15 pm 75 ML 105 min 3:30 pm 50 ML 75 min 7:00 pm 100ML 210 min 7:20 pm 75 ML 20 min 9:40 pm 75 ML 140 min Day Nine 12:35 am125 ML 175 min 1:20 am 60 ML 45 min 2:50 am 100 ML 90 min 6:20 am 125 ML210 min 8:15 am 40 ML 115 min 8:30 am 50 ML 15 min 11:30 am 100 ML 180min 12:35 pm 50 ML 65 min 3:05 pm 40 ML 210 min 5:25 pm 100 ML 140 min7:20 pm 100 ML 115 min 7:30 pm 25 ML 10 min 9:30 pm 125 ML 120 min 11:05pm 130 ML 95 min Day Ten 2:35 am 125 ML 210 min 2:40 am 60 ML 5 min 4:30am 100 ML 110 min 7:00 am 90 ML 150 min 10:00 am 110 ML 180 min 10:10 am40 ML 10 min 1:45 pm 100 ML 210 min 3:15 pm 40 ML 90 min 7:40 pm 150 ML265 min 7:50 pm 15 ML 10 min 10:45 pm 25 ML 175 min 10:55 pm 10 ML 10min Day Eleven 12:30 am 25 ML 95 min 12:40 am 10 ML 10 min 6:50 am 135ML 250 min 7:00 am 25 ML 10 min 1:20 pm 175 ML 420 min 5:00 pm 110 ML220 min 5:15 pm 75 ML 15 min 7:00 pm 100 ML 105 min 9:45 pm 50 ML 125min 9:50 pm 50 ML 5 min Day Twelve 1:00 am 175 ML 235 min 2:45 am 125 ML90 min 3:00 am 40 ML 15 min 5:20 am 70 ML 140 min 5:30 am 40 ML 10 min8:30 am 80 ML 180 min 8:40 am 75 ML 10 min

Steel Cup Time from prior Trial Time Urine Volume urination/interval10:50 pm 60 ML n/a 10:55 pm 30 ML 5 min First full Day - Day One 1:40 am100 ml 225 min 1:45 am 59 ml 5 min 7:05 am 125 ml 200 min 7:11 am 75 ml6 min 12:00 am 150 ml 289 min 12:07 pm 100 ml 7 min 1:50 pm 75 ml 103min 3:20 pm 85 ml 90 min 5:30 pm 75 ml 140 min 5:35 pm 60 ml 5 min 11:00pm 175 ml 325 min 11:06 pm 75 ml 6 min Day Two 2:00 am 100 ml 174 min2:06 am 75 ml 6 min 6:05 am 150 ml 239 min 6:10 am 75 ml 5 min 8:15 am125 ml 125 min 8:22 am 80 ml 7 min 10:20 am 90 ml 118 min 10:50 am 75 ml30 min 2:45 pm 75 ml 235 min 5:00 pm 80 ml 140 min 8:30 pm 75 ml 210 minDay Three 12:40 am 130 ml 250 min 12:44 am 40 ml 4 min 2:30 am 80 ml 116min 2:35 am 50 ml 5 min 5:50 am 100 ml 195 min 6:00 am 30 ml 10 min12:00 noon 175 ml 360 min 12:10 pm 100 ml 10 min 3:35 pm 125 ml 205 min3:42 pm 60 mil 7 min 9:10 pm 125 ml 328 min 11:30 pm 75 ml 140 min 11:36pm 100 ml 6 min Day Four 3:15 am 100 ml 219 min 3:21 am 90 ml 6 min 5:30am 125 ml 129 min 5:35 am 60 ml 5 min 9:10 am 100 ml 220 min 9:16 am 50ml 6 min 1:15 pm 110 ml 239 min 4:00 pm 140 ml 225 min 7:55 pm 110 ml235 min 8:00 pm 30 ml 5 min 11:20 pm 105 ml 200 min 11:27 pm 75 ml 7 minDay Five 1:34 am 135 ml 127 min 1:38 am 75 ml 4 min 3:38 am 150 ml 120min 3:45 am 75 ml 7 min 7:00 am 100 ml 210 min 7:08 am 105 ml 8 min 9:00am 100 ml 112 min 9:05 am 80 ml 5 min 9:15 am 75 ml 10 min 1:00 pm 150ml 225 min 4:20 pm 150 ml 190 min 4:28 pm 110 ml 8 min 8:20 pm 90 ml 232min 10:50 pm 60 ml 150 ml Day Six 2:45 am 60 ml 235 min 2:55 am 50 ml 10min 7:55 am 115 ml 240 min 8:01 am 50 ml 6 min

Quantitative analysis is provided below

Avg Time Interval between voids sessions (net of secondary/ tertiaryvoids, i.e. interval starts 15 min or less from completion of voidsession, # of double includes time voids (secondary or Longest Interval# of urinations from prior day # of voids tertiary voids in 15 betweenurination Day (full 24 hour period) where applicable) less than 50 MLmin interval or less) (over 24 hour period) Paper - Day One 16 133 min 25 175 min Paper - Day Two 12 141 min 3 3 200 min Paper - Day Three 10182 min 0 2 175 min Paper - Day Four 13 137.5 min 2 3 200 min Paper -Day Five 11 144.3 min 3 3 295 min Paper - Day Six 11 152.7 min 1 2 270min Paper Dav Seven 13 156 min 1 3 240 min Paper - Day Eight 14 121.4min 0 3 225 min Paper - Day Nine 14 130 min 3 3 210 min Paper -Day Ten12 173.8 min 5 4 265 min Paper- Day Eleven 10 165.8 min 3 4 420 minPaper Avg Paper - avg Paper - # of double voids 243.2 min - urinations#voids less (secondary or tertiary avg longest- per 24 hr than 50 MLvoids in 15 min interval daily interval 12.3/day 2.1/day or less)3.2/day Steel Day one 12 0 5 325 min Steel Day two 11 0 3 239 min SteelDay three 13 2 6 328 min Steel Day four 12 1 5 239 min Steel Day five 140 6 232 min Steel Avg Steel - avg Steel - # of double voids 272.6 min -Urinations #voids less (secondary or tertiary avg longest per 24 hr than50 ML voids in 15 min interval daily 12.4/day 0.6/day or less) interval5/day

The text table analyzes the sleep hours record in bolded italics in thetables.

Avg sleep interval (excluding double/tertiary Longest Interval voids -voids between # of nocturia (all within 15 urination (over Sleep Cyclevoids) minutes) sleep cycle) Paper Sleep 7 131.25 175 min Cycle #1 PaperSleep 8 128 150 min Cycle #2 Paper Sleep 6 216.7 270 min Cycle #3 PaperSleep 5 165 243 min Cycle #4 Paper Sleep 7 164 295 min Cycle #5 PaperSleep 7 174 300 min Cycle #6 Paper Sleep 6 130 240 min Cycle #7 PaperSleep 132.5 140 min Cycle #8 Paper Sleep 129.1 210 min Cycle #9 PaperSleep 5 141.3 210 min Cycle #10 Paper Sleep 6 173.3 250 min Cycle #11Paper Sleep 9 153 235 min Cycle #12 Paper avg # of Paper Avg sleep PaperAvg nocturia (all interval Longest Interval voids) (excluding between6.7 double/tertiary urination (over voids - voids sleep cycle) within 15247.1 min minutes) 167.1 min Steel Sleep 6 212.5 225 min Cycle # 1 SteelSleep 6 246 325 min Cycle # 2 Steel Sleep 6 187 250 min Cycle # 3 SteelSleep 6 162.7 219 min Cycle # 4 Steel Sleep 8 164.3 210 min Cycle # 5Steel Sleep 5 208.3 240 min Cycle # 6 Steel avg # of Steel Avg sleepSteel Avg nocturia (all interval Longest Interval voids) (excludingbetween 6.2 double/tertiary urination (over voids - voids sleep cycle)within 15 244.8 minutes) 196.8 min

What is claimed is:
 1. A method for initiating urination in a malecomprising contacting the penis and-or scrotum with a contact surfacearea, wherein said contact surface area has thermal conductivity greaterthan 20 watts per meter-kelvin, the contact surface area and initialtemperature being capable of producing sufficient thermal transfer toassist with the release of the urinary sphincter and initiate urination2. The method according to claim 1, wherein the contact surface area isat least 0.5 square inches.
 3. The method according to claim 1, whereinthe contact surface area is part of a vessel configured to reduce urinestream pressure requirements.
 4. The method according to claim 1,wherein the method is used to reduce the time interval between doublevoiding.
 5. The method according to claim 1, wherein the method is usedto reduce retained urine in the bladder.
 6. The method according toclaim 5, wherein the method is carried out to reduce retained urine fora given urination protocol for a given patient population by at least10%
 7. The method according to claim 1, wherein the method is used toincrease total sleep time.
 8. The method according to claim 7, whereinaverage sleep times are increased by 15% or more
 9. The method accordingto claim 1, wherein the method is used to reduce the activity ofantidiuretic hormone.
 10. The method according to claim 1, wherein thecontact surface area is chilled.
 11. The method according to claim 1,wherein the method reduces the risk and frequency of urinary tractinfections.
 12. The method according to claim 11, wherein prevalence ofurinary tract infections is reduced at least 10%